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Completed

NCT Number: NCT00904020

A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.

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Key information

Conditions

Postherpetic Neuralgia Back Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Low Back Pain Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Were currently receiving an analgesic regimen that contained gabapentin
  • Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
  • Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit
  • For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)

Exclusion criteria

  • Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
  • Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
  • Had received trigger point injections within 14 days prior to study entry
  • Had received Botox injections within 3 months prior to study entry
  • Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
  • Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Treatment and study plan

Lidoderm

Drug

Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.

Other names: Lidocaine patach 5%

Primary outcomes

  1. Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

Secondary outcomes

  1. Pain quality using the Neuropathic Pain Scale (NPS)

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

  2. Investigator and Patient Global Impression of Change

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

  3. Extent of numbness at the site of pain using the Numbness Questionnaire

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

  4. Patient Global Assessment of Pain Relief

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

  5. Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

  6. QoL: Pain interference (BPI Question 9)

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

  7. QoL: Patient Global Assessment of Patch Satisfaction

    Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

Important dates

Study start
2002
Primary completion
2002
First posted
May 19, 2009
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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